MAUDE Adverse Event Report: ICU MEDICAL TRIOX-PICC; CATHETER

Model Number 52516-15

Device Problem Calibration Error (1078)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

Lot review: no exception documents cited in work order.

Event Description

Optical module of catheter was not reading svo2.The cco box was changed out but same issues occurred.Facility reports that there was a critical delay in therapy and medical intervention was required.No other information was provided.

Manufacturer Narrative

Lot review: no exception documents cited in work order.Visual analysis: received one used 52516-15.There is residual blood observed but was flushed out of the catheter during decontamination.The proximal tubing is occluded.No visual anomalies.Functional analysis: initial calibration of the returned device was successful.It was observed that crosstalk between the two optic fibers was occurring.Crosstalk could possibly lead to inaccurate svo2 readings.Summary conclusion: the report of svo2 not reading could not be replicated.No defect was found and the heating coil was working within specifications.

Event Description

Optical module of catheter was not reading svo2.The cco box was changed out but same issues occurred.Facility reports that there was a critical delay in therapy and medical intervention was required.No other information was provided.

• Brand Name: TRIOX-PICC
• Type of Device: CATHETER
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• Manufacturer (Section G): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• Manufacturer Contact: holly imes ; 4455 atherton drive; salt lake city, UT 84117 ; 8012641747
• MDR Report Key: 7095041
• MDR Text Key: 95072517
• Report Number: 2025816-2017-00251
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00840619060305
• UDI-Public: 840619060305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: 52516-15
• Device Catalogue Number: 52516-15
• Device Lot Number: 3418977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1